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FDA Found Answer To Vibativ Dilemma Of Teratogenicity Vs. Microbial Resistance In REMS

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A Risk Evaluation and Mitigation Strategy that addresses the teratogenicity of Theravance’s Vibativ enabled FDA to manage an internal disagreement that pitted the drug’s risk to the unborn against the public health need for new antibiotics.
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